The following data is part of a premarket notification filed by Pearce Clinical Laboratories, Inc. with the FDA for Colorectal Cancer Risk Detector (tm).
| Device ID | K874180 |
| 510k Number | K874180 |
| Device Name: | COLORECTAL CANCER RISK DETECTOR (TM) |
| Classification | Reagent, Occult Blood |
| Applicant | PEARCE CLINICAL LABORATORIES, INC. 805 NO. SAN JACINTO Conroe, TX 77301 |
| Contact | Pearce, Phd |
| Correspondent | Pearce, Phd PEARCE CLINICAL LABORATORIES, INC. 805 NO. SAN JACINTO Conroe, TX 77301 |
| Product Code | KHE |
| CFR Regulation Number | 864.6550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-10-14 |
| Decision Date | 1988-09-30 |